PMA P100018S004

Device: PIPELINE EMBOLIZATION DEVICE
Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
PMA number: P100018
Supplement: S004
Product code: OUT
Decision date: 2012-03-22
Classification: Intracranial Aneurysm Flow Diverter
Generic name: Intracranial aneurysm flow diverter
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT EV3 NEUROVASCULAR, IRVINE, CALIFORNIA AS AN ADDITIONAL MANUFACTURING SITE FOR THE DEVICE.

Current openFDA PMA Record#

Device: PIPELINE EMBOLIZATION DEVICE
Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
PMA number: P100018
Supplement: S004
Product code: OUT
Generic name: Intracranial aneurysm flow diverter
Decision date: 2012-03-22
Decision code: APPR
Date received: 2011-09-19
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT EV3 NEUROVASCULAR, IRVINE, CALIFORNIA AS AN ADDITIONAL MANUFACTURING SITE FOR THE DEVICE.